Methods and apparatus for securing and deploying tissue anchors

ABSTRACT

Methods and apparatus for securing and deploying tissue anchors are described herein. A tissue manipulation assembly is pivotably coupled to the distal end of a tubular member. A reconfigurable launch tube is also pivotably coupled to the tissue manipulation assembly, which may be advanced through a shape-lockable endoscopic device, a conventional endoscope, or directly by itself into a patient. A second tool can be used in combination with the tissue manipulation assembly to engage tissue and manipulate the tissue in conjunction with the tissue manipulation assembly. A deployment assembly is provided for securing engaged tissue via one or more tissue anchors, the deployment assembly also being configured to disengage the anchors endoluminally or laparoscopically.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to methods and apparatus for securing anddeploying tissue anchors. More particularly, the present inventionrelates to methods and apparatus for endoluminally or laparoscopicallysecuring and deploying anchors within or against tissue, for instance,to form and/or secure tissue folds or to approximate regions of tissue,etc.

A number of surgical techniques have been developed to treat variousgastrointestinal disorders. One such example of a pervasive disorder ismorbid obesity. Conventional surgical treatment for morbid obesitytypically includes, e.g., bypassing an absorptive surface of the smallintestine, or reducing the stomach size. However, many conventionalsurgical procedures may present numerous life-threatening post-operativecomplications, and may cause atypical diarrhea, electrolytic imbalance,unpredictable weight loss and reflux of nutritious chyme proximal to thesite of the anastomosis.

Furthermore, the sutures or staples that are often used in surgicalprocedures for gastrointestinal disorders typically require extensivetraining by the clinician to achieve competent use, and may concentratesignificant force over a small surface area of the tissue, therebypotentially causing the suture or staple to tear through the tissue.Many of the surgical procedures require regions of tissue within thebody to be approximated towards one another and reliably secured. Thegastrointestinal lumen, for instance, includes four tissue layers, wherethe mucosa layer is the inner-most tissue layer followed by connectivetissue, the muscularis layer, and where the serosa layer is theouter-most tissue layer.

One problem with conventional gastrointestinal reduction systems is thatthe anchors (or staples) should engage at least the muscularis tissuelayer in order to provide a proper foundation. In other words, themucosa and connective tissue layers typically are not strong enough tosustain the tensile loads imposed by normal movement of the stomach wallduring ingestion and processing of food. In particular, these layerstend to stretch elastically rather than firmly hold the anchors (orstaples) in position, and accordingly, the more rigid muscularis and/orserosa layer should ideally be engaged. This problem of capturing themuscularis or serosa layers becomes particularly acute where it isdesired to place an anchor or other apparatus transesophageally ratherthan intra-operatively, since care must be taken in piercing the toughstomach wall not to inadvertently puncture adjacent tissue or organs.

One conventional method for securing anchors within a body lumen to thetissue is to utilize sewing devices to suture the stomach wall intofolds. This procedure typically involves advancing a sewing instrumentthrough the working channel of an endoscope and into the stomach andagainst the stomach wall tissue. The contacted tissue is then typicallydrawn into the sewing instrument where one or more sutures or tags areimplanted to hold the suctioned tissue in a folded condition known as aplication. Another method involves manually creating sutures forsecuring the plication.

One of the problems associated with these types of procedures is thetime and number of intubations needed to perform the various proceduresendoscopically. Another problem is the time required to complete aplication from the surrounding tissue with the body lumen. In the periodof time that a patient is anesthetized, procedures such as for thetreatment of morbid obesity or for GERD must be performed to completion.Accordingly, the placement and securement of the tissue plication shouldideally be relatively quick and performed with a minimal level ofconfidence.

Another problem with conventional methods involves ensuring that thestaple, knotted suture, or clip is secured tightly against the tissueand that the newly created plication will not relax under any slackwhich may be created by slipping staples, knots, or clips. Otherconventional tissue securement devices such as suture anchors, twistties, crimps, etc. are also often used to prevent sutures from slippingthrough tissue. However, many of these types of devices are typicallylarge and unsuitable for low-profile delivery through the body, e.g.,transesophageally.

Moreover, when grasping or clamping onto or upon the layers of tissuewith conventional anchors, sutures, staples, clips, etc., many of thesedevices are configured to be placed only after the tissue has beenplicated and not during the actual plication procedure.

BRIEF SUMMARY OF THE INVENTION

An example of a tool which may be utilized for endoluminally accessingtissue may generally comprise a flexible catheter or tubular body whichmay be configured to be sufficiently flexible for advancement into abody lumen, e.g., transorally, percutaneously, laparoscopically, etc.The tubular body may be configured to be torqueable such that when acontrol handle is manipulated and/or rotated by a practitioner fromoutside the patient's body, the longitudinal and/or torquing force istransmitted along the flexible body such that the distal end of body isadvanced, withdrawn, or rotated in a corresponding manner.

A tissue manipulation assembly may be located at the distal end of thetubular body and is generally used to contact and form tissue folds, asmentioned above. The tissue manipulation assembly may be connected tothe distal end of the tubular body via a pivotable coupling, and a lowerjaw member may extend distally from the pivotable coupling with an upperjaw member, in this example, pivotably coupled to the lower jaw membervia a jaw pivot. The location of the jaw pivot may be positioned atvarious locations along the lower jaw depending upon a number offactors, e.g., the desired size of the “bite” or opening for acceptingtissue between the jaw members, the amount of closing force between thejaw members, etc. One or both jaw members may also have a number ofprotrusions, projections, grasping teeth, textured surfaces, etc., onthe surface or surfaces of the jaw members to facilitate the adherenceof tissue therebetween.

A launch tube may extend from the handle, through tubular body, anddistally from the end of tubular body where a distal end of the launchtube is pivotally connected to the upper jaw member at a pivot. A distalportion of the launch tube may be pivoted into position within a channelor groove defined in upper jaw member to facilitate a low-profileconfiguration of the tissue manipulation assembly. When articulated,either via the launch tube or other mechanism, the jaw members may beurged into an open configuration to receive tissue in the jaw openingbetween the jaw members.

In operation, a shape-lockable endoscopic assembly may be advanced intoa patient's stomach per-orally and through the esophagus. Such anendoscopic assembly may generally comprise an endoscopic device, whichmay have a distal portion that may be articulated and steered toposition its distal end anywhere within the stomach. Once desirablyconfigured, the assembly may then be locked or rigidized to maintain itsshape or configuration to allow for procedures to be performed on thetissue utilizing any number of tools delivered therethrough.

The tissue manipulation assembly may be delivered into the patient whilein a low-profile configuration, e.g., transorally, through theshape-lockable endoscopic assembly, through an endoscope, an endoscopicdevice, or directly. Once desirably positioned, the launch tube may beurged proximally via its proximal end at handle. Because the jawassembly pivot and the relative positioning of the upper jaw pivot alonglower jaw member and launch tube pivot along upper jaw member, theproximal movement of the launch tube may effectively articulate upperjaw into an expanded jaw configuration. Proximally urging the launchtube may also urge the lower jaw member to pivot about the assemblypivot and form an angle relative to a longitudinal axis of the tubularbody. The opening of the upper jaw relative to the lower jaw creates ajaw opening for grasping or receiving tissue. Moreover, the tissuemanipulation assembly may also include a stop located adjacent to thejaw assembly pivot or within the pivot itself.

A second tool for initially engaging the tissue region of interest mayalso be deployed and utilized to engage the tissue and to position theengaged tissue between the jaws of the jaw assembly. Any number of toolsmay be used in combination with the tissue manipulation assembly. Oncethe tissue has been engaged between the jaw members, a needle assemblymay be urged through the launch tube to pierce through the graspedtissue. Once the needle assembly has been passed through the engagedtissue, one or more tissue anchors may be deployed for securing thetissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of one variation of a tissue manipulationassembly having a flexible body and a handle.

FIG. 1B illustrates a detail side view of a tissue manipulation assemblyin a low-profile configuration connected to the distal end of thetubular body via a pivotable coupling.

FIGS. 2A to 2C illustrate a method for articulating the tissuemanipulation assembly from a low-profile configuration to an openedconfiguration and to a closed jaw configuration for clamping upontissue, respectively.

FIGS. 3A and 3B show detail perspective views of the tissue manipulationassembly in an open and clamped configuration, respectively.

FIG. 4 shows an assembly view of how a needle deployment assembly may beintroduced through a handle and tubular body of the tissue manipulationassembly.

FIG. 5A shows a detailed assembly view of the needle deployment assemblyfrom FIG. 4.

FIG. 5B shows an exploded assembly view of the needle deploymentassembly from FIG. 5A.

FIG. 6 illustrates one example in which a shape-lockable endoscopicassembly may be advanced into a patient's stomach per-orally and throughthe esophagus with a tissue manipulation assembly advanced through afirst lumen and a tissue engagement member advanced through a secondlumen.

FIG. 7 illustrates a tissue manipulation assembly and examples ofvarious tools which may be used in combination with the tissuemanipulation assembly.

FIGS. 8A to 8D illustrate an example for performing an endoluminaltissue manipulation and securement procedure utilizing a tissuemanipulation assembly in combination with a separate tissue graspingtool within, e.g., a patient's stomach.

FIG. 9A shows one variation where a single tissue fold may be securedbetween tissue anchors using the tissue manipulation assembly.

FIG. 9B shows another variation where two or more tissue folds may besecured between tissue anchors using the tissue manipulation assembly.

FIGS. 10A and 10B illustrate a variation of the tissue manipulationassembly in a perspective and cross-sectional view, respectively, wherea number of reinforcement members or bars may be positioned along thelaunch tube to increase its column strength.

FIGS. 11A and 11B illustrate another variation of the tissuemanipulation assembly in a perspective and cross-sectional view,respectively, where a pull wire may be routed through the launch tube tofacilitate articulation of the launch tube and/or jaw assembly.

FIG. 12 illustrates yet another variation of the tissue manipulationassembly which may also utilize a pull wire connected directly to thelaunch tube.

FIG. 13 illustrates an exploded view of a variation of an anchorassembly and needle deployment assembly.

FIG. 14 illustrates an assembly view, partially in section, of theanchor assembly and needle deployment assembly variation of FIG. 13.

FIGS. 15A to 15F illustrate an exemplary method of using the anchorassembly and needle deployment assembly variation of FIGS. 13 and 14.

FIG. 16 illustrates a variation of the suture element for use with theanchor assembly and needle deployment assembly of FIGS. 13 to 15.

FIG. 17 illustrates a variation of the needle for use with the anchorassembly and needle deployment assembly variation of FIGS. 13 to 15.

FIG. 18 illustrates a variation of the control mechanisms for use withthe needle deployment assemblies of FIGS. 13 to 17.

FIGS. 19A to 19C illustrate an exemplary method of using anothervariation of the anchor assembly and needle deployment assembly.

FIGS. 20A to 20C are schematic views illustrating another variation ofthe needle deployment assembly.

FIGS. 21A to 21C illustrate another variation of the needle deploymentassembly utilizing a release suture or wire which may be routed througha looped terminal end of a suture element.

FIGS. 22A to 22C illustrate yet another variation of the needledeployment assembly utilizing a reconfigurable hook element which mayconfigure itself from a hooked configuration to an open or straightenedconfiguration.

FIGS. 23A to 23C illustrate yet another variation of the needledeployment assembly utilizing a release suture or wire with anobstructive element to be released from the release suture or wire.

DETAILED DESCRIPTION OF THE INVENTION

In manipulating tissue or creating tissue folds, a having a distal endeffector may be advanced endoluminally, e.g., transorally,transgastrically, etc., into the patient's body, e.g., the stomach. Thetissue may be engaged or grasped and the engaged tissue may bemanipulated by a surgeon or practitioner from outside the patient'sbody. Examples of creating and forming tissue plications may be seen infurther detail in U.S. patent application Ser. No. 10/955,245 filed Sep.29, 2004, which has been incorporated herein by reference above, as wellas U.S. patent appication Ser. No. 10/735,030 filed Dec. 12, 2003, whichis incorporated herein by reference in its entirety.

In engaging, manipulating, and/or securing the tissue, various methodsand devices may be implemented. For instance, tissue securement devicesmay be delivered and positioned via an endoscopic apparatus forcontacting a tissue wall of the gastrointestinal lumen, creating one ormore tissue folds, and deploying one or more tissue anchors through thetissue fold(s). The tissue anchor(s) may be disposed through themuscularis and/or serosa layers of the gastrointestinal lumen.

An illustrative side view of one example of a tool which may be utilizedfor endoluminally accessing tissue is shown in FIG. 1A, which showsassembly 10. The assembly 10 generally comprises a flexible catheter ortubular body 12 which may be configured to be sufficiently flexible foradvancement into a body lumen, e.g., transorally, percutaneously,laparoscopically, etc. Tubular body 12 may be configured to betorqueable through various methods, e.g., utilizing a braided tubularconstruction, such that when handle 16 is manipulated and/or rotated bya practitioner from outside the patient's body, the longitudinal and/ortorquing force is transmitted along body 12 such that the distal end ofbody 12 is advanced, withdrawn, or rotated in a corresponding manner.

Tissue manipulation assembly 14 is located at the distal end of tubularbody 12 and is generally used to contact and form tissue folds, asmentioned above. FIG. 1B shows an illustrative detail side view in whichtissue manipulation assembly 14 may be seen connected to the distal endof tubular body 12 via a pivotable coupling 18. Lower jaw member 20extends distally from the pivotable coupling 18 and upper jaw member 22,in this example, may be pivotably coupled to lower jaw member 20 via jawpivot 26. The location of jaw pivot 26 may be positioned at variouslocations along lower jaw 20 depending upon a number of factors, e.g.,the desired size of the “bite” or opening for accepting tissue betweenthe jaw members, the amount of closing force between the jaw members,etc. One or both jaw members 20, 22 may also have a number ofprotrusions, projections, grasping teeth, textured surfaces, etc., 24 onthe surface or surfaces of the jaw members 20, 22 facing one another tofacilitate the adherence of tissue between the jaw members 20, 22.

Launch tube 28 may extend from handle 16, through tubular body 12, anddistally from the end of tubular body 12 where a distal end of launchtube 28 is pivotally connected to upper jaw member 22 at launch tubepivot 30. A distal portion of launch tube 28 may be pivoted intoposition within a channel or groove defined in upper jaw member 22, tofacilitate a low-profile configuration of tissue manipulation assembly14. When articulated, either via launch tube 28 or other mechanism, asdescribed further below, jaw members 20, 22 may be urged into an openconfiguration to receive tissue in jaw opening 32 between the jawmembers 20, 22.

Launch tube 28 may be advanced from its proximal end at handle 16 suchthat the portion of launch tube 28, which extends distally from body 12,is forced to rotate at hinge or pivot 30 and reconfigure itself suchthat the exposed portion forms a curved or arcuate shape that positionsthe launch tube opening perpendicularly relative to upper jaw member 22.Launch tube 28, or at least the exposed portion of launch tube 28, maybe fabricated from a highly flexible material or it may be fabricated,e.g., from Nitinol tubing material which is adapted to flex, e.g., viacircumferential slots, to permit bending.

FIGS. 2A to 2C illustrate one method for articulating a tissuemanipulation assembly into an opened and closed configuration. As shownin FIG. 2A, the assembly may be delivered into a patient while in alow-profile configuration 40, e.g., transorally, through an endoscope,an endoscopic device, or directly. Once desirably positioned, launchtube 28 may be urged proximally via its proximal end at handle 16.Because of jaw assembly pivot 18 and the relative positioning of upperjaw pivot 26 along lower jaw member 20 and launch tube pivot 30 alongupper jaw member 22, the proximal movement of launch tube 28 mayeffectively articulate upper jaw 22 into an expanded jaw configuration42, as shown in FIG. 2B. Proximally urging launch tube 28 may also urgelower jaw member 20 to pivot about assembly pivot 18 and form an angle,a, relative to a longitudinal axis of tubular body 12. The opening ofupper jaw 22 relative to lower jaw 20 creates jaw opening 32 forgrasping or receiving tissue. Moreover, the tissue manipulation assemblymay also include a stop located adjacent to jaw assembly pivot 18 orwithin the pivot 18 itself.

Once launch tube 28 has been urged proximally, it may be locked intoplace thus locking the jaw configuration as well. Moreover, having thelaunch tube 28 articulate the jaw members 20, 22 in this variationeliminates the need for a separate jaw articulation and/or lockingmechanism. Once the tissue has been pulled or manipulated between jawmembers 20, 22, launch tube 28 may be pushed distally to actuate the jawmembers 20, 22 into a closed, grasping configuration 48, as shown inFIG. 2C, for engagement with the tissue. As launch tube 28 is urgeddistally through body 12, lower jaw member 20 may be maintained at theangle, a, relative to the tissue to further facilitate manipulation ofthe grasped tissue.

Launch tube 28 may further define a flexible portion 44 distally of arigid portion 46. Although launch tube 28 may be fabricated fromdifferent materials having differing flexibilities, it may also befabricated from a single material, as mentioned above, where theflexible portion 44 may configured, e.g., by slotting, to allow forbending of the launch tube 28 in a plane to form a single curved orarcuate section while the rigid section 46 may extend at least partiallyinto tubular body 12 to provide column strength to launch tube 28 whileit is urged distally upon upper jaw member 22 and upon any tissueengaged thereby, as seen in the FIG. 2C.

Once the tissue has been engaged between jaw members 20, 22, a needleassembly may be urged through handle 16 and out through launch tube 28.The needle assembly may pass through lower jaw member 20 via needleassembly opening 50 defined in lower jaw member 20 to pierce through thegrasped tissue. Once the needle assembly has been passed through theengaged tissue, one or more tissue anchors may be deployed for securingthe tissue, as described in further detail in U.S. patent applicationSer. No. 10/955,245, which has been incorporated by reference above.

FIGS. 3A and 3B show detail perspective views of the tissue manipulationassembly. As shown in FIG. 3A, lower jaw member 20 and upper jaw member22 may be seen its open configuration 42 when the launch tube has beenurged proximally. Launch tube channel 52 may also be seen defined withinupper jaw member 22 for providing a space for positioning the launchtube when in the low-profile configuration. Also shown is needleassembly opening 50 defined within lower jaw member 20 for passage ofthe needle assembly therethrough. FIG. 3B shows the assembly in itsclosed jaw configuration where the launch tube has been urged distallyin which it rotates about launch tube pivot 30 such that the opening thelaunch tube become perpendicular relative to the jaw members 20, 22.

Although one particular variation of the jaw members 20, 22 is shown,this is not intended to be limiting in jaw member configuration oroperation. Other variations may include various placement of the jawsrelative to one another, alternative configurations for articulating thejaw members, alternative configurations for the launch tube placement,etc. Other variations are intended to be within the scope of thisdisclosure.

As mentioned above, a needle deployment assembly 60 may be deployedthrough the assembly 10 by introducing needle deployment assembly 60into the handle 16 and through tubular body 12, as shown in the assemblyview of FIG. 4, such that the needle assembly 66 is advanced from thelaunch tube and into or through approximated tissue. Once the needleassembly 66 has been advanced through the tissue, the anchor assembly 68may be deployed or ejected. Anchor assembly 68 is normally positionedwithin the distal portion of tubular sheath 64, which extends fromneedle assembly control or housing 62. Once the anchor assembly 68 hasbeen fully deployed from sheath 64, the spent needle deployment assembly60 may be removed from assembly 10 and another needle deploymentassembly may be introduced without having to remove assembly 10 from thepatient. The length of sheath 64 is such that it may be passed entirelythrough the length of tubular body 12 to enable the deployment of needleassembly 66 into and/or through the tissue.

FIG. 5A shows a detailed assembly view of the needle deployment assembly60 from FIG. 4. In this variation, elongate and flexible sheath orcatheter 64 may extend removably from needle assembly control or housing62. Sheath or catheter 64 and housing 62 may be interconnected viainterlock 70 which may be adapted to allow for the securement as well asthe rapid release of sheath 64 from housing 62 through any number offastening methods, e.g., threaded connection, press-fit, releasable pin,etc. Needle body 72, which may be configured into any one of thevariations described above, may extend from the distal end of sheath 64while maintaining communication between the lumen of sheath 64 andneedle opening 74.

Elongate pusher 76 may comprise a flexible wire or hypotube which istranslationally disposed within sheath 64 and movably connected withinhousing 62. A proximally-located actuation member 78 may be rotatably orotherwise connected to housing 62 to selectively actuate thetranslational movement of elongate pusher 76 relative to sheath 64 fordeploying the anchors from needle opening 74. Anchor assembly 68 may beseen positioned distally of elongate pusher 76 within sheath 64 fordeployment from sheath 64. Needle assembly guides 80 may also be seenprotruding from housing 62 for guidance through the locking mechanismdescribed above. FIG. 5B shows an exploded assembly view of the needledeployment assembly 60 from FIG. 5A. As seen, sheath 64 may bedisconnected from housing 62 via interlock 70 to reveal the elongatepusher 76 connected to housing 62 and the distal and proximal anchors82, 84, respectively, of anchor assembly 68.

With respect to the anchor assemblies, the types of anchors shown anddescribed are intended to be illustrative and are not limited to thevariations shown. For instance, the tissue anchor variations may alsoinclude “T”-type anchors while other variations may includereconfigurable “basket”-type anchors, which may generally comprise anumber of configurable struts or legs extending between at least twocollars or support members or reconfigurable mesh structures extendingbetween the two collars. Other variations of these or other types ofanchors are also contemplated for use in an anchor assembly. Moreover, asingle type of anchor may be used exclusively in an anchor assembly;alternatively, a combination of different anchor types may be used in ananchor assembly. Furthermore, the different types of cinching or lockingmechanisms are not intended to be limited to any of the particularvariations shown and described but may be utilized in any of thecombinations or varying types of anchors as practicable.

Other variations for the needle assemblies and for the anchors aredescribed in further detail in U.S. patent application Ser. No.10/955,245, which has been incorporated by reference above.

In operation when manipulating and securing tissue within a patient'sbody, a separate elongate shaft having a tool on or near the distal endof the shaft may be utilized in conjunction with the tissue manipulationassembly 14. Such tools are generally utilized in endoluminal procedureswhere the tools are delivered through an endoscope. Generally, severaldifferent tools may be utilized for performing a procedureendoluminally.

As illustrated in FIG. 6, one such example is shown in which ashape-lockable endoscopic assembly 90 may be advanced into a patient'sstomach S per-orally and through the esophagus E. Such an endoscopicassembly 90 may generally comprise an endoscopic device which may have adistal portion which may be articulated and steered to position itsdistal end anywhere within the stomach S. Once desirably configured,assembly 90 may then be locked or rigidized to maintain its shape orconfiguration to allow for procedures to be performed on the tissueutilizing any number of tools delivered through the assembly 90.Shape-lockable assembly 90 and its variations are described in furtherdetail in U.S. patent application Ser. No. 10/734,562 filed Dec. 12,2003, which is incorporated herein by reference in its entirety.

Shape-lockable assembly 90 may be generally comprised of shape-lockableendoscopic body 92 having an articulatable distal portion 96. Theendoscopic body 92 may define at least first and second lumens 98, 100,respectively, through the endoscopic body 92 through which one or moretools may be deployed into the stomach S. Additional lumens may beprovided through shape-lockable endoscopic body 92, such as avisualization lumen 101, through which an endoscope may be positioned toprovide visualization of the region of tissue. Alternatively, an imagersuch as a CCD imager or optical fibers may be provided in lumen 101 toprovide visualization. An optional thin wall sheath 94 may be disposedthrough the patient's mouth, esophagus E, and possibly past thegastroesophageal junction GEJ into the stomach S. Shape-lockable body 92may be advanced through esophagus E (and through sheath 94, if utilized)and into stomach S while disposed in a flexible state.

Distal steerable portion 96 of endoscopic body 92 may be thenarticulated to an orientation, e.g., whereby distal portion 96facilitates engagement of tissue near and/or inferior to the patient'sgastroesophageal junction GEJ. Accordingly, distal steerable portion 96may comprise a number of steering features, as described in furtherdetail in U.S. patent application Ser. No. 10/734,562, incorporatedabove. With distal steerable portion 96 disposed in a desiredconfiguration or orientation, endoscopic body 92 may be reversiblyshape-locked to a rigid state such that the endoscopic body 92 maintainsits position within the stomach S. Various methods and apparatus forrigidizing endoscopic body 92 along its length are also described infurther detail in U.S. patent application Ser. No. 10/734,562,incorporated above.

FIG. 6 shows tissue manipulation assembly 14 having been advancedthrough first lumen 98 and a tissue engagement member 102 positionedupon flexible shaft 104 advanced through second lumen 100. As the tissuewall of a body lumen, such as the stomach, typically comprises an innermucosal layer, connective tissue, the muscularis layer and the serosalayer. To obtain a durable purchase, e.g., in performing a stomachreduction procedure, tissue engagement member 102 may be advanced intocontact with the tissue and preferably engages the tissue F such thatwhen the tissue engagement member 102 is pulled proximally to draw theengaged tissue F between the jaw members 20, 22 of tissue manipulationassembly 14, at least the muscularis tissue layer and the serosa layeris drawn into tissue manipulation assembly 14.

As tissue manipulation assembly 14 may be utilized to grasp and securethe engaged tissue, any number of tools may be utilized with tissuemanipulation assembly 14, e.g., through shape-lockable endoscopic body92, to engage and manipulate the tissue of interest relative to tissuemanipulation assembly 14. FIG. 7 illustrates tissue manipulationassembly 14 upon flexible body 12 with handle 16 and examples of varioustools which may be used in combination with tissue manipulation assembly14.

Turning to FIG. 7, one example of a tool utilizable in combination withtissue manipulation assembly 14 is shown in tissue engagement member 102as a tissue piercing helix or corkscrew structure upon flexible shaft104 (as shown in FIG. 6). Tissue engagement member 102 may be rotatedabout its longitudinal axis to engage the tissue of interest by rotatinghandle 106 located on the proximal end of flexible shaft 104.Alternatively, a tool having aggressive tissue graspers 108 positionedupon flexible shaft 110 and articulatable via handle 112 may be utilizedin combination with tissue manipulation assembly 14. Another alternativetool may be tissue graspers 114 positioned upon flexible shaft 116 andarticulatable via handle 118. Tissue graspers 114 may have atraumaticgrasping surfaces. In yet another alternative, an endoscope 122 havingoptical fibers or imager 120 may be utilized for providingvisualization. Endoscope 122 may be articulated via handle 124 at itsproximal end.

The examples of the various tools as shown and described are intendedmerely to be illustrative of the range of tools which may be usable withassembly 14 and are not intended to be limiting in any manner. Anynumber of other tools may be accordingly utilized and are intended to bewithin the scope of this disclosure.

An example of performing an endoluminal tissue manipulation andsecurement procedure utilizing tissue manipulation assembly 14 incombination with a separate tissue grasping tool within, e.g., apatient's stomach, is illustrated in FIGS. 8A to 8D. As shown in FIG.8A, once shape-lockable endoscopic body 92 has been introduced into thepatient, e.g., trans-orally, trans-anally, percutaneously, etc., anddesirably positioned relative to a tissue region of interest 130,endoscopic body 92 may be rigidized to maintain its configuration withinthe patient body. Alternatively, it may be left in a flexible stateduring the procedure.

The tissue region of interest 130 as well as the procedure may bevisualized through visualization lumen 101 or a separate imager, asdescribed above. In either case, tissue manipulation assembly 14 andtissue engagement member 102 may be advanced distally out fromendoscopic body 92 through their respective lumens 98, 100. Tissueengagement member 102 may be advanced into contact against the tissuesurface, as shown in FIG. 8A, and then rotated via its proximal handleuntil the tissue is engaged. The engaged tissue F may be pulledproximally relative to endoscopic body 92 and tissue manipulationassembly 14 may be actuated via its proximally located handle into anopen expanded jaw configuration for receiving the engaged tissue F, asshown in FIG. 8B.

Alternatively, once the tissue F has been engaged, tissue manipulationassembly 14 may be advanced distally in its open configuration onto theengaged tissue. In yet another variation, tissue engagement member 102may be omitted entirely and tissue manipulation assembly 14 may beutilized alone to grasp onto the tissue region of interest 130. In yetanother alternative, a second tissue manipulation assembly may be usedin combination with tissue manipulation assembly 14.

Turning back to FIG. 8B, tissue manipulation assembly 14 may bearticulated to receive the engaged tissue F. As shown in FIG. 8C, onceengaged tissue F is positioned between jaw members 20, 22, the launchtube may be urged proximally to actuate upper jaw member 22 to grasp orclamp upon the tissue F. Tissue engagement member 102 may be retractedfrom the tissue F or it may be left within the tissue while tissuemanipulation assembly engages and secures the tissue F.

FIG. 8D shows a partial cross-sectional view of the tissue F whileengaged to tissue manipulation assembly 14. Tissue engagement member 102has been omitted from this view only for the sake of clarity. Asmentioned above, member 102 may be left remaining in the tissue F,disengaged from tissue F, or disengaged and removed entirely fromendoscopic body 92, if so desired, and another tool may be advancedthrough lumen 100 to facilitate the procedure. Once jaw members 20, 22have been actuated to clamp or grasp upon tissue F by the launch tube,the launch tube may be automatically positioned into its anchordeployment configuration. The needle assembly may then be urged viamanipulation from its proximal end at handle 16 through the launch tubeto pierce preferably through a dual serosa layer through engaged tissueF and past lower jaw member 20. As described above, the engaged tissue Fpositioned between the jaw members 20, 22 is desirably engaged such thatthe needle body 72, when urged through the tissue F, is disposed throughthe muscularis and/or serosa layers of the engaged tissue F. Once needlebody 72 has passed through tissue F, one or more expandable tissueanchors may be ejected from needle body 72 through needle opening 74.

Because needle body 72 may penetrate the tissue wall twice, it exitswithin the body lumen if utilized within, e.g., the stomach, thusreducing the potential for injury to surrounding organs. As describedabove, needle body 72 may define needle lumen or opening 74 throughwhich an expandable anchor, e.g., distal anchor 82 and/or proximalanchor 84, may be situated during deployment and positioning of theassembly. A single suture or flexible element 132 (or multiple sutureelements) may connect distal anchor 82 and proximal anchor 84 to oneanother and end in terminal loop 134. For instance, element 132 maycomprise various materials such as monofilament, multifilament, or anyother conventional suture material, elastic or elastomeric materials,e.g., rubber, etc.

Once distal anchor 82 has been ejected, needle body 72 may be urgedproximally back through tissue F, where proximal anchor 84 may then beejected from needle body 72 with suture 132 still connecting the twoanchors 82, 84 through tissue F. Alternatively, tissue manipulationassembly 14, with suture 132 still depending therefrom, may bedisengaged from tissue F and the procedure may be repeated at a secondregion of tissue where proximal anchor 84 may then be ejected.

FIG. 9A shows one variation where a single fold F may be secured betweenproximal anchor 82 and distal anchor 84. With both anchors 82, 84disposed externally of the launch tube and suture 132 connecting thetwo, proximal anchor 84 may be urged into contact against tissue F. Asthe anchors are urged against tissue fold F, distal anchor 82 or aportion of suture 132 may be configured to provide any number ofdirectionally translatable locking mechanisms 136 which provide formovement of an anchor along suture 132 in a first direction andpreferably locks, inhibits, or prevents the reverse movement of theanchor back along suture 132.

FIG. 9B shows another variation where a at least two folds F₁ and F₂ maybe secured between proximal anchor 82 and distal anchor 84. After theanchors have been ejected from needle body 72, the anchors may beapproximated towards one another over suture 132 thus bringing folds F₁and F₂ towards one another. Although a single tissue fold and a dualfold are shown in these examples, any number of folds or tissue ridgesmay be created using the tools disclosed herein. Moreover, theseexamples are merely intended to be illustrative and not limiting in anyway. In either case, it may be generally desirable to form the tissuefolds such that serosa-to-serosa contact 138 occurs between the layersof secured tissue, although this may not be necessary.

Various examples of cinching devices and methods which may be utilizedwith the tools and devices herein are described in further detail inU.S. patent application Ser. No. 10/840,950 filed May 7, 2004, which hasbeen incorporated herein above.

In using the launch tube as a jaw actuation mechanism, other variationsof the launch tube may be utilized to ensure sufficient strength andforce transmission in tissue manipulation assembly 14 for jaw memberactuation. One such example is shown in the perspective view of FIG.10A, which shows launch tube 44 having a number of reinforcement membersor bars 140 aligned along one or both sides of the launch tube toprovide for additional column strength. Each of the reinforcementmembers 140 may be pivotally attached to launch tube 44 via pivotmembers 144 rotatably secured within pivot channels 142, as seen in thelaunch tube cross-section in FIG. 10B. Moreover, each of the pivotmembers 144 may define cooperating adjacent members relative to oneanother while maintaining contact to allow for the transmission of forcebetween the members 144. Pivot members 144 may be positioned along thelength of the exposed launch tube or a portion of the launch tube;moreover, a single side of the launch tube may have pivot members 144attached thereto. Alternatively, rather than utilizing pivot members,portions of the launch tube itself may be simply thickened to increaseits column strength and force transmission capabilities.

In another variation, as shown in FIG. 11A and the launch tubecross-section in FIG. 11B, a pull wire 152 may be routed through tubularbody 12 and launch tube 44 through a pull wire lumen 150 to provide alaunch tube and jaw actuation mechanism separate from the launch tubeactuation itself. Pull wire 152 may be manipulated via its proximal endat handle 16 by pulling or pushing pull wire 152 to actuate launch tube44 and/or jaw members 20, 22. Alternatively, as seen in FIG. 12, pullwire 152 may be routed through tubular body 12 and connected directly tolaunch tube 44 at pull wire attachment point 154 rather than routing itthrough the launch tube. Again, manipulation of pull wire 152 may beutilized to articulate the launch tube configuration as well as jawmember articulation.

Referring now to FIGS. 13 and 14, a variation of the anchor assembly andthe needle deployment assembly is described. As with previouslydescribed needle deployment assembly 60, assembly 60′ comprises needleassembly control or housing 62, tubular sheath 64 and needle assembly 66having needle body 72 with opening 74. Elongate pusher 76 is configuredfor translation within sheath 64 via actuation member 78. Pusher 76illustratively comprises a hypotube having lumen 77 definedtherethrough.

In the variation of FIGS. 13 and 14, locking mechanism 136 of anchorassembly 68′ is disposed proximal of proximal anchor 84, and the anchorassembly is positioned within the distal portion of tubular sheath 64,such that the distal region of pusher 76 abuts locking mechanism 136.Suture or flexible element 132′ comprising distal knot or protrusion 133extends proximally from the knot in a manner that connects distal anchor82, proximal anchor 84 and locking mechanism 136. Element 132′ thenfurther extends through lumen 77 of pusher 76 to a proximal region ofassembly 60′ such that element 132′ may be manipulated by a medicalpractitioner from outside a patient. The medical practitioner may, forexample, engage previously described suture loop 134, or may engage someother control element 134′, such as a ring or handle, disposed at theproximal end of suture element 132′. As will be apparent, in anothervariation, element 132′ may extend to the proximal region of assembly60′ alongside pusher 76 rather than within a lumen of the pusher.

With reference to FIGS. 15, a method of using anchor assembly 68′ andneedle deployment assembly 60′ is described. For the purposes ofillustration, the assemblies are shown securing tissue without use of atissue manipulation assembly. However, it should be understood that theassemblies alternatively may be used in combination with a tissuemanipulation assembly, such as previously described tissue manipulationassembly 14 of assembly 10.

In FIG. 15A, needle deployment assembly 60′ has been positioned inproximity to approximated tissue T. The assembly is advanced such thatneedle assembly 66 pierces the tissue and is advanced through and acrossthe tissue, as in FIG. 15B. Pusher 76 is advanced within the lumen ofsheath 64 via actuation member 78, such that distal anchor 82 of anchorassembly 68′ is ejected through opening 74 of needle body 72 of needleassembly 66 on the distal side of approximated tissue T. Needledeployment assembly 60′ and pusher 76 then are retracted such that thepusher and needle assembly 66 again are disposed on the proximal side ofthe approximated tissue, as in FIG. 15C. Next, pusher 76 is distallyadvanced relative to sheath 64 to eject proximal anchor 84 from thesheath.

In FIG. 15D, with the proximal and distal anchors of anchor assembly 68′disposed 25 on either side of the approximated tissue, the anchorassembly is cinched by retracting control element 134′ relative toneedle deployment assembly 60′. Pusher 76 abuts locking mechanism 136and urges it distally during proximal retraction of element 134′, whichshortens the length of suture element 132′ disposed between distalanchor 82 and proximal anchor 84, thereby cinching anchor assembly 68′.Locking mechanism 136 ensures that the 30 anchors remain cinched byresisting distal passage of element 132′ through the mechanism, therebyresisting subsequent separation of the proximal and distal anchors.

With anchor assembly 68′ cinched, pusher 76 is retracted relative tosheath 64 such that needle assembly 66 engages suture element 132′, asin FIG. 15E. The needle assembly cuts the suture proximal of lockingmechanism 136, as in FIG. 15F. The medical practitioner may facilitatecutting of the suture element by manipulating control element 134′ ofanchor assembly 68′ and/or by manipulating needle assembly control 62 ofneedle deployment assembly 60′.

Referring now to FIG. 16, a variation of the suture element of anchorassembly 68′ is described. In FIG. 16, suture element 132″ comprisessegment 135 of reduced integrity. The segment may for example, comprisefewer suture strands or may be reduced in integrity via chemical,electrical, thermal or physical processing, etc. Segment 135 may locallyreduce the tensile strength of element 132″ to a desired threshold. Whenused to cinch anchor assembly 68′ in combination with anchor deploymentassembly 60′, the segment may obviate a need to cut the suture withneedle assembly 66 after cinching of the anchor assembly. Specifically,the anchor assembly may be cinched to a desired tension after whichsegment 135 plastically deforms and snaps, leaving the anchor assemblycinched and in place.

With reference to FIG. 17, a variation of the needle assembly of needledeployment assembly 60′ is described. Needle body 72′ of needle assembly66′ may comprise one or more recessed cut-outs 73 having sharpened edgesE for cutting the suture element. After cinching of anchor assembly 68′,the suture element may be snagged within a cut-out 73 and cut by thesharpened edge of the cut-out.

Referring now to FIG. 18, alternative control mechanisms for needledeployment assembly 60′ are described. Actuation member 78′ forcontrolling pusher 76 may be integrated with needle assembly control62′, such that the actuation member is advanceable in controlledincrements relative to the needle assembly control via detents 63 of theneedle assembly control that coact with actuation member 78′.

With reference to FIGS. 19, another variation of the anchor assembly andneedle deployment assembly is shown. Control element 134′ of anchorassembly 68′ is coupled to or abuts needle assembly control 62′ ofneedle deployment assembly 60′. When distal anchor 82 of anchor assembly68′ is disposed on the distal side of approximated tissue T, as in FIG.19A, the proximal and distal ends of suture element 132′ areconstrained. Thus, as seen in FIGS. 19A and 19B, advancement of pusher76 via actuation member 78′ advances both proximal anchor 84 and lockingmechanism 136 of anchor assembly 68′. This causes the anchor assembly tobe progressively cinched as the proximal anchor is advanced. Once theanchor assembly has been ejected from sheath 64, as in FIG. 19B, andadequately cinched, as in FIG. 19C, suture element 132′ may be cutproximal of the locking mechanism, e.g., with needle assembly 66 asdescribed previously.

Referring to FIGS. 20, a variation of the needle deployment assembly isdescribed. Pusher 76′ comprises suture ports 79 through which sutureelement 132 of anchor assembly 68′ is routed. As seen in FIG. 20A, withpusher 76′ disposed within tubular sheath 64 of needle deploymentassembly 60′, suture element 132′ passes out of the pusher between thesuture ports and is disposed between the pusher and the interior wall ofthe tubular sheath. As seen in FIG. 20B, when pusher 76′ is advancedthrough and distal of needle assembly 66, e.g., to eject proximal anchor84 of anchor assembly 68′ from the needle deployment assembly and/or tocinch the anchor assembly, the section of suture element 132′ betweenthe suture ports is exposed. Subsequent retraction of the pusherrelative to the needle assembly causes the section of exposed suture tocontact the sharpened edge of needle assembly 66, thereby severingsuture element 132′ as in FIG. 20C.

Turning now to FIGS. 21, another variation of the needle deploymentassembly is shown. In this variation, suture element 132′″ may form aterminal loop 158 through which a release suture or wire 156 may bepassed. Release suture or wire 156 may be routed through the length ofthe needle deployment assembly and through pusher 76, as describedabove, and both release suture or wire 156 and terminal loop 158 mayboth be situated within pusher 76, as shown in FIG. 21A. Afterdeployment of the anchors into tissue and cinching of the assembly, asdescribed above, one end of release suture or wire 76 may be pulled ortensioned proximally in the direction shown by arrow 162, as in FIG.21B. This pulling may draw a terminal end of release suture or wire 156through pusher 76 until terminal loop 158 of suture element 132′″ hasbeen released therefrom, as shown in FIG. 21C.

In yet another variation shown in FIG. 22A, terminal loop 158 of sutureelement 132′″ may be seen restrained within pusher 76 via reconfigurablehook 164 of release wire 156′. Here, release wire 156′ may be fabricatedfrom a shape memory or superelastic alloy material, such as Nitinol,which has been preformed to reconfigure its terminal end from a hook 164configuration to a straightened or opened configuration once releasedfrom the constraints of pusher 76. Thus, after deployment and cinchingof the anchor assembly, release wire 156′ may be advanced distallythrough pusher 76, as shown in FIG. 22B, until reconfigurable hook 164,which is retained in a hooked or obstructive configuration within thelumen of pusher 76, has been advanced out of pusher 76. Once free fromthe constraints of the lumen, hook 164 may reconfigure itself into anopened or straightened configuration to thereby release terminal loop158 of suture element 132′″, as shown in FIG. 22C. Hook 164 havingreleased terminal loop 158, may then be withdrawn proximally back intopusher 76 in its straightened configuration.

In another variation shown in FIG. 23A, a terminal end of suture element132′″ may have an obstructive or enlarged element 160, e.g., a knot,formed thereon. The terminal end of suture element 132′″ withobstructive element 160 may be looped around release suture or wire 156and retained within the lumen of pusher 76. After anchor deployment andcinching, release suture or wire 156 may be drawn distally with loopedobstructive element 160 retained securely thereto, as shown in FIG. 23B,until obstructive element 160 and release suture or wire 156 have beenadvanced out of pusher 76. Once free from the constraints of the pusherlumen, obstructive element 160 may be released from release suture orwire 156, as shown in FIG. 23C, to thus release suture element 132′″.

Although a number of illustrative variations are described above, itwill be apparent to those skilled in the art that various changes andmodifications may be made thereto without departing from the scope ofthe invention. Moreover, although specific configurations andapplications may be shown, it is intended that the various features maybe utilized in various combinations and in various types of proceduresas practicable. It is intended in the appended claims to cover all suchchanges and modifications that fall within the true spirit and scope ofthe invention.

1. An anchor deployment assembly comprising: at least one tissue anchorhaving a length of suture depending therefrom; and an elongate memberconfigured for advancement within a body lumen, wherein the elongatemember is configured to deploy the at least one tissue anchor, andwherein the elongate member is further configured to disengage thesuture at a location proximal to the at least one tissue anchor upondeployment of the at least one tissue anchor.
 2. The anchor deploymentassembly of claim 1, wherein the elongate member is configured to severthe suture at the proximal location upon deployment of the at least onetissue anchor.
 3. The anchor deployment assembly of claim 2, wherein theelongate member comprises a needle assembly having a piercing tip, thepiercing tip configured to sever the suture.
 4. The anchor deploymentassembly of claim 3, wherein the needle assembly defines at least onecut-out having sharpened edges for severing the suture.
 5. The anchordeployment assembly of claim 1 further comprising a tissue grasping tooladapted to be advanced endoluminally into a body lumen, wherein theanchor deployment assembly is configured for advancement through thetissue grasping tool.
 6. The anchor deployment assembly of claim 5,wherein the tissue grasping tool further comprises a first jaw member, asecond jaw member pivotably coupled along the first jaw member, and alaunch tube member adapted to urge the first and second jaw membersbetween a low-profile delivery configuration and an expanded graspingconfiguration.
 7. The anchor deployment assembly of claim 6, wherein theanchor deployment assembly is configured for advancement through thelaunch tube member.
 8. The anchor deployment assembly of claim 6 whereina distal end of the launch tube member is pivotably coupled to thesecond jaw member.
 9. The anchor deployment assembly of claim 5 furthercomprising a tissue engagement device having a distal end effectoradapted to reversibly engage tissue and further adapted to be positionedendoluminally within the body lumen adjacent to the tissue graspingtool.
 10. The anchor deployment assembly of claim 9 wherein the distalend effector comprises a helical member having a tissue piercing tip.11. The anchor deployment assembly of claim 9 wherein the distal endeffector comprises a grasper for reversibly engaging the tissue.
 12. Theanchor deployment assembly of claim 1 further comprising an endoscopicdevice having a flexible body, the flexible body adapted to be rigidizedto maintain an arbitrary shape, wherein the anchor deployment assemblyis configured for advancement through the endoscopic device.
 13. Theanchor deployment assembly of claim 12, wherein the endoscopic devicecomprises a steerable distal section.
 14. A method of securing tissuewithin a hollow body organ, comprising: advancing a needle of an anchordeployment assembly through engaged tissue; deploying a distal tissueanchor through the needle on a distal side of the engaged tissue;retracting the needle to a proximal side of the engaged tissue;deploying a proximal tissue anchor through the needle on the proximalside of the engaged tissue; and severing a suture element connecting theproximal and distal tissue anchors with the needle proximal of theproximal anchor, thereby releasing the proximal and distal anchors fromthe anchor deployment assembly.
 15. The method of claim 14 furthercomprising cinching the proximal and distal anchors to secure theengaged tissue prior to severing the suture element.
 16. The method ofclaim 14, wherein severing the suture element with the needle furthercomprises severing the suture element via sharpened cut-outs defined inthe needle.
 17. The method of claim 14 wherein deploying the proximaland distal anchors through the needle further comprises advancing apusher through the needle.
 18. The method of claim 14 furthercomprising, prior to advancing the needle through the engaged tissue,endoluminally advancing a tissue grasping tool pivotably coupled to adistal end of an elongate member into the hollow body organ; reversiblyengaging the tissue within the hollow body organ with a distal endeffector positioned adjacently to the tissue grasping tool; and clampingthe engaged tissue with the tissue grasping tool.
 19. The method ofclaim 18 wherein endoluminally advancing comprises advancing the tissuegrasping tool transesophageally into a stomach.
 20. The method of claim18 further comprising, prior to advancing the needle through the engagedtissue, positioning the anchor deployment assembly at least partiallywithin the tissue grasping tool.
 21. A method of securing tissue withina hollow body organ, comprising: deploying a tissue anchor assemblythrough a needle of an anchor deployment assembly, thereby securingengaged tissue; and severing a suture element attached to the tissueanchor assembly with the needle proximal of the proximal anchor, therebyreleasing the tissue anchor assembly from the anchor deploymentassembly.